基于COSMIN指南对中医证候疗效评价量表的系统评价OA
A Systematic Review of Traditional Chinese Medicine Syndrome Efficacy Evaluation Scales Based on the COSMIN Guidelines
目的 系统评价中医证候疗效评价量表的方法学质量及测量学特性,为中医临床实践选用高质量评估工具提供参考.方法 检索中国知网、万方数据库、维普网、中国生物医学文献数据库、PubMed、Cochrane Library、Embase和Web of Science自建库至2025年4月2日收录的涉及中医证候疗效评价量表测量学特性评价的文献,提取资料,依据健康测量工具共识标准(COSMIN)评估纳入量表的方法学质量及测量学特性,并结合证据分级标准形成相应推荐意见.结果 共纳入46项研究,涵盖22个普适性证候疗效评价量表和24个疾病特异性证候疗效评价量表,均未报告跨文化效度和测量误差.推荐等级显示,2个量表符合A级推荐,建议临床使用;38个量表为B级推荐,提示存在潜在应用价值但需进一步验证;6个量表为C级推荐,建议进一步完善.结论 现有中医证候疗效评价量表存在方法学质量参差不齐、测量学特性报告不完整及修订重视度不足等问题,未来应加强中医证候量表研制的规范化设计,完善关键测量属性的验证流程,注重对量表进行动态修订,为证候疗效的精准评价提供高质量工具支持.
Objective To systematically evaluate the methodological quality and measurement properties of traditional Chinese medicine(TCM)syndrome efficacy evaluation scales,and to provide evidence-based references for selecting high-quality assessment tools in TCM clinical practice.Methods China National Knowledge Infrastruc-ture(CNKI),Wanfang Data,VIP Database,Chinese Biomedical Literature Database(CBM),PubMed,the Cochrane Library,Embase,and Web of Science were searched from inception to April 2,2025,for studies evaluating the mea-surement properties of TCM syndrome efficacy evaluation scales.Data were extracted,and the methodological quality and measurement properties of the included scales were assessed according to the consensus-based standards for the selection of health measurement instruments(COSMIN).Recommendation levels were formulated based on the grading of evidence.Results A total of 46 studies were included,involving 22 generic syndrome efficacy evaluation scales and 24 disease-specific syndrome efficacy evaluation scales.None of the scales reported cross-cultural validity or measurement error.According to the recommendation grades,2 scales met Grade A recommendations and are sug-gested for clinical use;38 scales were classified as Grade B,indicating potential applicability but requiring further validation;and 6 scales were classified as Grade C,suggesting the need for further refinement.Conclusion Existing TCM syndrome efficacy evaluation scales exhibit substantial variability in methodological quality,incomplete report-ing of measurement properties,and insufficient attention to scale revision.Future efforts should emphasize standardized design in the development of TCM syndrome scales,strengthen validation procedures for key measurement properties,and prioritize dynamic revision of scales,thereby providing high-quality tools to support the precise evaluation of syn-drome efficacy.
苏凯林;冯贞贞;王佳佳;王露;赵贵香;李建生
河南中医药大学第一附属医院,河南省郑州市金水区人民路19号,450003||河南中医药大学第一临床医学院||河南中医药大学呼吸疾病中医药防治省部共建协同创新中心河南中医药大学第一附属医院,河南省郑州市金水区人民路19号,450003||河南中医药大学第一临床医学院||河南中医药大学呼吸疾病中医药防治省部共建协同创新中心河南中医药大学第一附属医院,河南省郑州市金水区人民路19号,450003||河南中医药大学第一临床医学院||河南中医药大学呼吸疾病中医药防治省部共建协同创新中心河南中医药大学第一附属医院,河南省郑州市金水区人民路19号,450003||河南中医药大学第一临床医学院||河南中医药大学呼吸疾病中医药防治省部共建协同创新中心河南中医药大学第一附属医院,河南省郑州市金水区人民路19号,450003||河南中医药大学第一临床医学院||河南中医药大学呼吸疾病中医药防治省部共建协同创新中心河南中医药大学第一附属医院,河南省郑州市金水区人民路19号,450003||河南中医药大学第一临床医学院||河南中医药大学呼吸疾病中医药防治省部共建协同创新中心
中医证候疗效评价量表测量学特性COSMIN指南系统评价
traditional Chinese medicine syndromesefficacy evaluationscalesmeasurement propertiesconsensus-based standards for the selection of health measurement instruments guidelinessystematic review
《中医杂志》 2026 (4)
416-424,9
国家重点研发计划中医药现代化重点专项(2024YFC3505302)河南省国家中医药传承创新中心科研专项(2023ZXZX1126)河南省"双一流"创建科学研究专项(HSRP-DFCTCM-2023-3-01,HSRP-DFCTCM-2023-4-09)
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